—#184072

Product

Kangaroo Connect 500ml Bag Set, Non-Sterile, Product Code 77500FD - Product Usage: single-use tubing sets used with pumps in the delivery of nutritional feeding product.

FDA product code: LZH — Pump, Infusion, Enteral
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K153074
Affected lot / code info: All lots of products manufactured in the below timespan: July 1, 2015 and July 20, 2019

Why it was recalled

The feeding spike sets may leak at the interface of the tube and spike connector.

Root cause (FDA determination)

Process control

Action the firm took

A Product Correction Notice dated 922/20 was sent to customers. Cardinal Health had previously notified customers of a Medical Device Product Advisory in December 2019 due to the potential risk of leaks with Kangaroo enteral feeding spike sets*. The purpose of this communication is to inform you that we have updated this notification to include all unexpired lots manufactured to date, in addition, we have added two additional product codes of Kangaroo Connect 500ml and 1000ml bag sets to the product correction notice. The Product Correction Notice is for all unexpired lots of the below Kangaroo enteral feeding spike sets and all lots of Kangaroo Connect 500ml and 1000ml bag sets manufactured between July 1, 2015 and July 20, 2019. We continue to receive complaints of leaking at the interface of the tube and spike connector, in addition to complaints of leaking due to PVC tubing disconnecting from the cassette in Connect bag sets. 1) INSPECT your inventory for affected product. 2) COMMUNICATE with all personnel that utilize these feeding sets the risk of leaks at the interface of the tube and spike connector in Kangaroo enteral feeding spike sets and the risk of PVC tubing disconnecting from the cassette in Kangaroo Connect Bag Sets causing leaking. 3) INSPECT the feeding set for leaks after the pump has been primed, after the infusion has started, and throughout the infusion process. " If a leak is detected the feeding set must be discarded and a new feeding set must be obtained. Inspect the new feeding set for leaks in the same manner. 4) NOTIFY any customers to whom you may have distributed or forwarded affected product about this product advisory. 5) RETURN the enclosed acknowledgment form via fax to 847-689-9101 or 614-652-9648 or email to gmb-fieldcorrectiveaction@cardinalhealth.com, whether or not you have affected product. Please contact the Customer Service group for any questions related to this action: " Hospital800-964-5227

Recalling firm

Firm: Cardinal Health
Address: 200 LLC 15 Hampshire St, Bldg 5, Mansfield, Massachusetts 02048-1113

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2020-09-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #184072. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.